1. Field of Invention
The present invention relates, in general, to the forming of a structure on or around a body part of an animal or human being. More specifically, it relates to the field of orthopedic bandaging materials, methods of making the same and uses thereof. Described herein is also a method of using a novel bandaging material in immobilization of a fractured body part.
2. Description of Related Art
Splinting and casting are the two most common methods of externally immobilizing orthopedic injuries. Splinting is the preferred method in the acute short term care setting since a non-circumferential treatment method allows natural swelling, which occurs during the initial inflammatory phase. Furthermore, a splint can be removed more easily than a circumferential cast, allowing regular inspections of the injury site.
However, splinting is not an appropriate treatment method when fractures are potentially unstable (e.g. fractures requiring reduction, segmental or spiral fractures, dislocation fractures) and can be utilized only for acute immobilization to allow swelling while awaiting definitive care. Casting is therefore the mainstay of treatment for most fractures because it generally provides more effective immobilization of the injury. However, this technique requires more skill and time to apply and has a higher risk of complications if not applied properly (e.g. skin breakdown, necrosis, and compartment syndrome).
Both immobilization methods are applicable for several different types of fractures and therefore skin lesions, soft-tissue injuries, and neurovascular status of the involved extremity are carefully documented before selecting splint or cast application.
The materials utilized for commonly used large volume casting applications include the following:                plain-weave gauze fabrics coated with calcium sulphate hemi-hydrate;        knitted fibreglass substrates impregnated with a polyurethane resin; and        knitted polyester fabrics, impregnated with a clear polyurethane resin        
Although casts manufactured of synthetic materials (DE 26 51 089, U.S. Pat. No. 4,376,438) are lighter, more durable and water resistant than plaster-of-Paris casts (WO 0035501), they are not superior in all respects. Many of the materials are toxic or at least difficult to dispose of. However, also their properties of use are in to some degree inadequate. For example, certain of the synthetic casting materials are considered more difficult to apply than plaster-of-Paris, and the conformability of the synthetic casting materials is reportedly inferior to that of plaster-of-Paris.
A cast which is poorly moulded will loosen more rapidly as soft tissue swelling resolves, and therefore use of synthetic casting materials is not recommended when there is an extensive soft tissue swelling. Also the problem of internal ridging predisposing to skin rubbing occurs more frequently in synthetic casts. In the case of lower limb walking casts, the lower weight of synthetic casts may not have significant dividends in terms of a reduction in the energy required to walk, as other factors, such as the angle of ankle fixation, have been shown to be more important than cast weight.
In addition to the above mentioned synthetic polyurethane products, various composites consisting of polycaprolactone homopolymers (PCLs) and fibrous materials are potentially interesting materials for orthopedic applications (WO 94/03211, WO 2007/035875 and US 2008/0262400). The PCLs have good strength properties and are biologically degradable. However, the PCL/fibrous material combinations do not meet all requirements of casting roll tape material. On the contrary, PCL-natural fiber composites have several disadvantages in a roll form like easy de-laminating feature after hardening, low dimensional stability during heating to application temperature, at application temperature (e.g. Cobracast) polymer particles will attach to skin requiring washing, and difficult coiling procedure at application temperature. Also excess of flexibility is found disadvantageous for circumferential casting applications; may cause easily pressure sores.
It is an object of the present invention to eliminate at least a part of the problems related to conventional splinting systems (in particular for circumferential application) and the above-mentioned problems of current products related either to their toxicity, complexity of structures and use or insufficient rigidity for splinting the limbs and body extremities.